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Version Number: 1.0

Version Date: 8/4/2019

MDS-G34

Guidance on Requirements for

Unique Device Identification (UDI) for Medical Devices

This document has been published after being distributed for

public comments dated on 10/12/2018 for 30 days.

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Table of Contents

Introduction ..................................................................................................................................... 3

Purpose .................................................................................................................................... 3

Scope……… ........................................................................................................................... 3

Background ............................................................................................................................. 3

Chapter One: UDI Requirements .................................................................................................... 4

Chapter Two: Additional Requirements ........................................................................................ 12

Chapter Three: Device Traceability .............................................................................................. 17

Chapter Four: UDI in Healthcare Delivery ................................................................................... 18

Annexes ......................................................................................................................................... 19

Annex (1): Definitions & Abbreviations ................................................................................... 20

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Introduction

Purpose

The purpose of this guidance is to specify the SFDA requirements for UDI for medical devices.

Scope………

This guidance applies to the following:

A. All medical devices and their accessories that will be supplied to the KSA market, except

custom-made medical devices, investigational medical devices and investigational IVD

medical device.

B. Manufacturers, authorized representative, importers, distributors, and healthcare providers.

Background

SFDA/MDS has issued this guidance document in order to support SFDA’s activities specified in

Chapter Nine of the "Medical Devices Interim Regulation" issued by Saudi Food and Drug

Authority Board of Directors decree No. (1-8-1429) dated 29/12/1429 H and amended by Saudi

Food and Drug Authority Board of Directors decree No. (4-16-1439) dated 27/12/2017 that is in

relation to safeguard activities.

The UDI system aims to increasing patient safety and optimizing patient care by facilitating the

following:

− Traceability of medical devices, especially for field safety corrective actions.

− Control of devices at the ports, especially for identification of counterfeits and recalled

devices.

− Identification of medical devices at the point of use.

− Identification of medical devices in adverse events.

− Reduction of medical errors.

− Safe and effective use of devices.

− Documentation and longitudinal capture of data on medical devices.

The purpose of SFDA’s UDI System is to provide standardized granular identification of medical

devices (and their accessories) and associated device-specific meta-data to support numerous and

varied public-health and safety initiatives. These include device traceability, timely identification

of counterfeits, recalls, adverse event reporting (both the specific identification of devices in

individual reports – as well as the ability to aggregate reports), the inclusion of specific devices in

various types of clinical information systems (such as patient records), as well as the inclusion of

device information in population-based data sets, such as insurance data. This System will also

allow integration of information across various government and non-government systems and

processes to improve workflow and communication.

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Chapter One: UDI Requirements

A. General UDI Requirements:

1. The marking of the UDI is an additional requirement – it does not replace any other

marking or labeling requirements.

2. A label or package that currently contains, or should contain, a Production Identifier (e.g.,

expiration (use by) date, lot number) as a discrete information element shall not remove

that information from the label or package because it is also being conveyed in the UDI.

3. The provisional accredited UDI Issuing Agencies shall be GS1, HIBCC and ICCBBA.

Maintenance of their accreditation is covered in Chapter One, Section (G).

4. The manufacturer shall assign and manage the UDI following the chosen issuing agency’s

specifications, standards and guidelines.

5. The UDI shall contain two parts: the UDI-DI and the UDI-PI(s).

− The UDI-DI is unique to a specific manufacturer’s device and provides access

to the information in the SAUDI-D.

− The UDI-DI shall be globally unique at all levels.

− If a lot number, serial number, software identification, or expiration (use by)

date is on the label or package, it shall be included in the UDI-PI.

− If there is also a manufacturing date on the label or package, it does NOT need

to be included in the UDI-PI if there are other PIs in the UDI and the

manufacturing date is not used to control the product.

− If the manufacturing date is the only PI, then it shall be included in the UDI.

6. The UDI shall be presented in two forms:

− Easily readable plain-text (also known as HRI), and

− AIDC technology.

7. The information encoded in the UDI (both AIDC and plain-text/HRI) may also include

other data, such as quantity or internal reference number, which is not considered part of

the UDI.

8. The HRI format shall follow the rules of the UDI issuing agency; it shall be the full, proper

HRI, including AIs, and NOT a mix of HRI and non-HRI text.

9. If the AIDC technology is not evident upon visual examination of the label or package, the

label or package shall disclose the presence of AIDC technology.

10. When AIDC carriers other than the UDI are part of the product labelling, the UDI shall be

easily and readily identifiable.

11. If linear barcodes are used, the entire UDI shall be concatenated into a single barcode.

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12. Barcodes shall be verified according to the appropriate ISO/IEC standard and they shall

meet the issuing agency’s grading standards.

13. If the manufacturer is using RFID technology, a linear or 2D barcode shall also be provided

on the label.

14. The UDI shall be readable during normal use and throughout the intended life of the device.

15. The UDI shall be placed so that the AIDC can be accessed during normal operation or

storage.

16. If the UDI is readily readable and in the case of AIDC scannable through the device’s

package, then the placing of the UDI on the “outer” package shall not be required.

B. Direct Marking (DM)

1. Reusable devices subject to the UDI requirements shall also bear a DM UDI on the device

itself if the device is intended to be used more than once and intended to be reprocessed

between uses.

2. The DM UDI shall be permanent and readable during normal use and throughout the

intended life of the device.

3. If the device’s primary label is on the device itself and is permanent – a separate DM UDI

is not required. However, the UDI label requirements will take precedent.

4. The UDI provided through the DM UDI may be:

− Identical to the UDI that appears on the label of the device, or

− A different UDI used to distinguish the unlabeled/unpackaged device.

5. When a device shall bear a UDI as a DM, the UDI may be provided through either or both

of the following:

− Easily readable plain-text/HRI;

− AIDC technology, or any alternative technology, that will provide the UDI of

the device on demand.

6. A device is exempt from the DM requirement if the manufacturer can adequately

demonstrate and document that:

− Any type of DM would interfere with the safety, performance or effectiveness

of the device;

− The device cannot be directly marked because it is not technologically

feasible; or

− The device has been previously directly marked.

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C. The UDI-DI Lifecycle

1. A new, unique UDI-DI is required whenever there is a change made to a device or its

attributes, and the change:

− Results in a new DI record,

− Results in a new version or model,

− Could lead to ambiguity in the identification of the device,

− Could affect the traceability of the device,

− Creates a new package, or

− Is to any of these SAUDI-D data elements:

o Issuing Agency

o Primary UDI-DI Number

o Quantity

o Brand/Trade Name

o Version or Model

o Clinically Relevant Size

o Labeled as Single Use

o Device required to be labeled as containing natural rubber latex

o MRI safety information (if not already labeled as Safe, Unsafe, or

Conditional)

o Device Packaged as Sterile

o Requires Sterilization Prior to Use

o Critical warnings or contraindications that appear on the device’s label

2. If the new UDI-DI is an update to a previously entered UDI-DI, then this relationship shall

be entered in SAUDI-D.

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D. Saudi Arabia UDI Database (SAUDI-D)

1. The manufacturer, or its authorized representative, shall submit and maintain the

appropriate data to the SAUDI-D for all devices subject to this guidance.

2. The manufacturer, or its authorized representative, shall implement and use standard

industry practices, methods, and procedures for data validation prior to submission.

3. The data shall be reconfirmed in SAUDI-D annually (data review, update and attestation

and is enforced by the SAUDI-D).

4. SFDA may request additional information, updates, or data confirmations at any time.

5. The data for new UDI-DI shall be available in SAUDI-D at the time the device is placed

on the market. For changes not requiring a new UDI-DI, the manufacturer shall update the

relevant record within 10 working (working) days of making the change.

6. All specified (non-private) data in the SAUDI-D will be made publicly available. Data

relating to devices no longer on the market shall be retained in the SAUDI-D.

7. The manufacturer, or its authorized representative, shall provide to the Saudi UDI database

(SAUDI-D) the following information for each Primary UDI-DI (defined as the UDI-DI

on the device’s primary label), or for those situations where there is no device label or

package containing the label, the DM UDI-DI, or the Unit of Use UDI-DI (as applicable).

7.1 All of the following device attribute information shall be provided in English,

unless stated otherwise (all fields are required unless otherwise noted):

7.1.1 The GTIN-14 (GS1) [and for those devices intended exclusively for

retail Point of Sale (POS), the GTIN-12/13 provided in a 14-digit

format], HIBC-LIC (HIBCC), or ISBT 128-PPIC (ICCBBA)

7.1.2 The establishment national registry number of the authorized

representative or local manufacturer

7.1.3 The medical device national listing number

7.1.4 The MDMA number

7.1.5 Name and address of the manufacturer (as labeled)

7.1.6 Name and address of the authorized representative (as labeled)

7.1.7 Brand/Trade/Generic name (as labeled; if no formal brand or trade

name is used or registered, enter generic device name that users are

accustomed to using)

7.1.8 Arabic version of Brand/Trade/Generic name – for OTC or home-use

devices

7.1.9 If exists, the version/model name/number or other high-level

identifier (e.g., Basic UDI-DI) that links a group of devices with the

same intended purpose, risk class and essential design and

manufacturing characteristics. Note that this is a manufacturer

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specified identifier – and is in addition to, and different from, the

GMDN Preferred Term identified in 7.1.35 below.

7.1.10 Catalog number

7.1.11 Device description – as labeled, in the labeling, or presented in

marketing material, including a website.

7.1.12 Arabic version of device description – for OTC or home-use devices

7.1.13 Quantity (for primary UDI-DI) – number of units in this device or

package

7.1.14 Unit of use DI number (when the number of units (quantity) >1) [can

be used in multiple DI records]

7.1.15 Clinically relevant size (as indicated on the label) – if the device is

available in more than one size and this information is necessary for

the hospital, clinician, or patient to know or use.

7.1.16 Production identifier(s) included in the UDI [lot/batch number (y/n),

serial number (y/n), expiration (use by) date (y/n), manufacturing date

(y/n), and/or software version number (y/n)]

7.1.17 If the same device can be provided to the KSA market with different

DIs – the other equivalent DIs that are about the same or equivalent

device and how the equivalent DIs are different [controlled

vocabulary – e.g., regional difference, language, voltage] than the

primary DI (separate DI records for the other DIs may, or may not, be

in SAUDI-D).

7.1.18 Previous DI (see Chapter One, section (C)) – the UDI-DI that was

changed because there was a change made to a device or its attributes

that resulted in a new DI record, a new version or model, or a new

package.

7.1.19 Is this a configurable device UDI-DI (y/n)

− If yes, and the configurable device UDI is not physically on

the label/device, but rather presented electronically,

where/how it can be found (free text)

7.1.20 Labeled as a single-use device (y/n)

7.1.21 Reprocessed single-use device (y/n)

7.1.22 Disposal/Scraping method – if the label or labeling specifies a

disposal or scraping methods (free text)

7.1.23 Device packaged/labeled as sterile (y/n)

7.1.24 Requires sterilization prior to (re-)use (y/n)

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7.1.25 If #24 is yes (not #23 above), sterilization method (from a specified

list of values) to inform the end user of the sterilization methods that

may be used to sterilize the device, if in fact the manufacturer of said

device intends the end user to sterilize device prior to use, or as

applicable, reuse

7.1.26 The maximum number of reuses (where the label indicates the

maximum number of reprocessing cycles)

7.1.27 Device labeled as containing natural rubber latex or dry natural rubber

(y/n)

7.1.28 Device labeled as "Not made with natural rubber latex" (y/n)

7.1.29 Prescription use (Rx) and/or Over the Counter (OTC) (one or both,

never neither)

7.1.30 Home-use (y/n)

7.1.31 MRI safety status (safe, unsafe, or conditional – or label does not

contain)

7.1.32 Special storage conditions (if labeled) (if none, state “none”)

7.1.33 Storage and handling conditions (as indicated on the label or in the

instructions for use) (if none, state “none”)

7.1.34 Critical warnings or contra-indications (as indicated on the device

label) (if none, state “none”)

7.1.35 GMDN Preferred Term code (auto-populates name and definition) –

note that ideally only one term Preferred Term is used/entered.

7.1.36 Risk class of the device linked to MDMA (premarket registration

path)

7.1.37 URL for additional information, such as electronic instructions for use

(optional)

7.1.38 Customer Contact – phone and email

7.2 For devices subject to DM:

7.2.1 The device is subject to the DM requirement (y/n)

7.2.2 If yes, the device is subject to the DM requirement, but the

manufacturer is claiming the following exemption (a. interfere with

safety, performance or effectiveness; b. not technologically feasible;

or c. previously marked)

7.2.3 If the DM UDI is different than the label UDI:

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− Is the UDI-DI different (y/n): if yes, list the DM DI [can be

used in multiple DI records]

− If the DM UDI contains PIs that are different than those used

in the label UDI, the different PIs used in the DM UDI

[defaults to primary DI PIs]: lot number (y/n), serial number

(y/n), expiration (use by) date (y/n), manufacturing date (y/n)

− The DM UDI is presented as:

− Plain-text/human-readable interpretation (HRI) (y/n)

− AIDC (y/n)

− An alternative technology (y/n) – if yes, describe (free text)

7.3 For devices packages (repeatable for multiple packages):

7.3.1 The Package UDI-DI number

7.3.2 Package type (free text, e.g., case, carton, box)

7.3.3 Quantity per package

7.3.4 The UDI-DI of the next lower device/package contained within this

package

7.3.5 If the package contains PIs that are different than those used in the

label, the PIs used in this package UDI [defaults to primary DI PIs]:

lot number (y/n), serial number (y/n), expiration (use by) date (y/n),

manufacturing date (y/n)

7.3.6 Package discontinuation date (for package configurations no longer

offered)

7.4 For kits

7.4.1 The UDI-DIs of all devices assigned or labeled with a UDI-DI within

the kit, whether marked or not.

7.5 For end of commercial distribution

7.5.1 Date no longer available on the market (that is, commercial

distribution end date, date device is no longer offered for sale)

E. Compliance Dates

1. All UDI Requirements shall apply:

− For Class D devices – (6) months after the SAUDI-D is available.

− For Class B and C devices – (1) years after the SAUDI-D is available.

− For Class A devices – (2) years after the SAUDI-D is available.

− For the DM requirements – (1) years after applicable class compliance date.

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F. Request for an Exception from or Alternative to a UDI Requirement

1. A manufacturer or its authorized representative may submit a request for an exception from

or alternative to any of the requirements of this guidance.

2. A written request for an exception or alternative shall:

− Identify the device or devices that would be subject to the exception or

alternative;

− Identify the specific parts of this guidance for an exception or alternative;

− If requesting an exception, explain why you believe the requirements are not

feasible;

− If requesting an alternative, describe the alternative and explain why it would

provide for more accurate, precise, or rapid device identification than the

requirements or how the alternative would better ensure the safety or

effectiveness of the device that would be subject to the alternative.

G. Management of UDI Issuing Agencies

1. The provisional accredited issuing agencies, GS1, HIBCC, and ICCBBA, shall provide

a point of contact for the SFDA – and other information deemed necessary by SFDA to

maintain accreditation.

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Chapter Two: Additional Requirements

1. Stand-alone Software (Software as a Medical Device)

1.1. The term Stand-alone Software (SaS) or Software as a Medical Device (SaMD) means

software intended to be used for one or more medical purposes that performs this

purpose without being part of a hardware medical device.

1.2. SaS/SaMD that is distributed in both a physical, packaged form and in a form that is

not packaged (e.g., when downloaded) may use the same or a different UDI.

1.3. A UDI shall be applied to the physical media containing SaS/SaMD.

1.4. A UDI shall be provided on a readily accessible screen for the user in an easily-

readable plain-text format (e.g., in an about, help or start-up screen).

1.5. Software lacking a user interface (e.g. middleware for image conversion) shall be

capable of transmitting the UDI through an Application Programming Interface (API).

1.6. Only the plain-text/HRI portion of the UDI shall be required in the software display

and shall include the relevant AIs.

1.7. In addition to the change rules outlined in Chapter One, section (C), a new UDI-DI

shall be required whenever there is a modification that changes:

a. the original performance and effectiveness,

b. the safety or the intended use of the Software, or

c. the interpretation of data.

2. Implantable Devices

2.1. All active implantable devices shall be controlled by serial number.

2.2. Manufacturers of implantable devices shall provide an “implant card” to the patient

with information allowing the identification of the device, including its UDI.

2.3. The following implants are exempted from the need to provide an implant card:

sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates,

wires, pins, clips and connectors.

2.4. The full UDI (UDI-DI and UDI-PI) of an implantable device shall be readily available,

either electronically or readable (scannable), at the point of implantation.

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3. Configurable Devices

3.1. A UDI shall be allocated to the configurable device in its entirety and shall be called

the configurable device UDI.

3.2. The configurable device UDI shall be placed on the assembly that will not be

exchanged during the lifetime of the system and shall be identified as the Configurable

device UDI.

3.3. Alternatively, the configurable device UDI can be presented electronically (e.g.,

through a computer interface) – and not physically located on the label. If so, then the

location and how to access it shall be entered into SAUDI-D.

3.4. Each component, sub-system or part that can be removed or separated from the

configuration or is available and distributed on its own (placed on the market) shall

have its own, separate UDI and meet all of the other UDI requirements.

4. Device constituent parts of “Combination Products”

4.1. When a device, when placed on the market or put into service, incorporates a substance

which, if used separately, would be considered to be a medicinal product, the medical

device(s), and/or its components, shall meet the UDI requirements.

4.2. However, if the device is intended to administer a medicinal product and the product

forms a single integral product which is intended exclusively for use in the given

combination and which is not reusable, the product shall be governed by appropriate

regulatory pathway and identification.

5. Components

5.1. Each component shall have its own, separate UDI and meet all of the other UDI

requirements of this guidance, if it:

− is available and distributed on its own (placed on the market), or

− can be installed or removed by the end-user (regardless of whether it is

commercially available and distributed on its own).

5.2. A component that significantly changes the intended purpose, safety or performance

of the device shall, for the purposes of UDI, be considered a remanufacturing

operation – and as such subject the entire device to a new UDI-DI.

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6. Single Use Device Packaging Exception

6.1. Individual single-use devices, which are labeled and packaged individually, are not

required to have the UDI on the individual device label/package if all of the following

conditions are thoroughly documented and met – the single-use devices are:

− All of the same version or model,

− Distributed together in a single package,

− Stored in that package until removed for use,

− Not intended for individual distribution, and

− Not implantable devices.

6.2. The primary UDI will be on the package of these individual single-use devices.

6.3. When this exception is used, SAUDI-D will require that a Unit of Use DI be assigned to

the unmarked individually labeled and packaged device and entered into the database.

7. Kits (which includes other non-homogenous package configurations)

7.1. A kit shall have its own, unique UDI (DI and PI) – referencing this specific collection

of devices.

7.2. The UDI-DIs of all devices within the kits, whether marked or not, shall be entered

into the SAUDI-D.

8. Convenience Kit/IVD Kit/Procedure Pack exception

8.1. For the purposes of this exception, a convenience kit, IVD kit or procedure pack,

which is a specific kind of kit, means a combination of medical products packaged

together and placed on the market with the purpose of being used for a single, specific

medical procedure or purpose.

8.2. The contents of a convenience kit, IVD kit, or procedure pack are intended to remain

in its original packaging until used by the end-user, and not replaced or repackaged,

and all devices are consumed or discarded after opened and used for the single,

intended medical procedure or purpose.

8.3. The convenience kit, IVD kit, or procedure pack shall have its own UDI.

8.4. The device contents of a convenience kit, IVD kit, or procedure pack shall also have

its own UDI, unless the device is:

8.4.1 An individual single-use disposable device, which cannot be used

outside the context of the convenience kit or procedure pack, or

8.4.2 Otherwise exempt from having a UDI on the label or package of the

device that is in the convenience kit or procedure pack.

8.5. The UDI-DIs of all devices within the kits/packs, whether marked or not, shall be

entered into the SAUDI-D.

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9. Shipping Containers

9.1. A UDI is not required to be placed on any shipping container.

10. Devices Sold at Retail

10.1. For devices intended exclusively for retail point of sale (POS), the UDI-PI(s) of the

UDI’s AIDC do not need to appear on the point of sale package (that is, in the

EAN/UPC/EAN data carrier).

10.2. Higher levels of packaging, not intended for retail Point of Sale, shall contain the full

UDI.

10.3. A device intended both for retail POS and use in clinical environments, e.g., hospitals,

shall also contain the full UDI on the label and packaging, in addition to the retail POS

data carrier.

11. Own Brand/Private Labelers

11.1. For the purposes of UDI, an Own Brand or Private Labeler, who labels or relabels a

device from a third party under his own name and/or Trade/Brand name, is considered

the manufacturer of the devices – and is responsible for the UDI of the labeled or

relabeled device.

12. Existing Inventory Exception

12.1. A finished device manufactured and labeled prior to the applicable compliance date

may be distributed without being UDI compliant for an additional (1) year after the

applicable compliance date. This exception does not apply to the DM requirement.

13. Reprocessed , Relabeled, Repackaged, Refurbished, Remanufactured, and Serviced Devices

13.1. Reprocessors of single use medical devices, re-labelers, re-packagers, re-furbishers,

and re-manufacturers, shall create their own, new UDI for the reprocessed, relabeled,

repackaged, refurbished, or remanufactured medical device, which shall replace the

OEM’s UDI where it exists.

13.2. The new UDI shall meet all of the requirements of this guidance.

13.3. The re-processor, re-labeler, re-packager, re-furbisher, or re-manufacturer shall keep,

where available, a record of the UDI of the original device.

13.4. The act of servicing a device, if returned to the original user, does not in and of itself

subject the device to UDI. However, if the serviced device is not necessarily returned

to the original user, the serviced device is subject to UDI.

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14. Verification and Traceability

14.1. The manufacturer, authorized representative, importer, distributor and health

institution shall store and maintain, in an easily searchable electronic format, the UDI

of the devices which they have both received and distributed.

14.2. Authorized representatives, importers and distributors shall verify, in the SAUDI-D,

that a UDI-DI has been properly assigned by the manufacturer and appropriately

appears on the device’s label and packages.

14.3. Where a retail pharmacy and other point of sale shop distributes medical devices, they

shall store and maintain, in an easily searchable electronic format, the UDI of the

devices which they have received and distributed.

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Chapter Three: Device Traceability

A. Import Control

1. Importers shall submit, for each UDI-DI being imported into the KSA market:

− The applicable Production Identifiers (UDI-PI(s)),

− Quantity of lot-controlled devices,

− Shipment date (when expected to arrive at the designated port), and

− Destination (e.g., specific distributor, hospital).

B. Track & Trace

1. All serialized medical device will be entered into the SFDA Track and Trace system to track

the device through its supply chain activities and usage in medical facilities (e.g., hospitals,

healthcare providers, point of sales, medical supply companies, etc.).

2. Through Track and Trace process, importers and distributors shall submit and confirm their

products information.

3. Database information:

− The SAUDI-D will submit serialized medical device data into the SFDA Track and

Trace system.

− The SFDA Track and Trace system will track the serialized medical device.

− The SAUDI-D will have access to query the status of any serialized medical device

through the supply chain activities – i.e., ability to locate a medical device for

postmarket patient safety activities.

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Chapter Four: UDI in Healthcare Delivery

The adoption, implementation and use of UDIs across and throughout the healthcare ecosystem by

health systems, hospitals, healthcare providers, patients, insurance companies, and others will bring

about significant cost, quality, safety, and efficiency improvements in the delivery and management

of medical-device related healthcare.

The documentation and use of a device’s UDI throughout healthcare will vastly improve the:

− Accurately and efficiency of the supply chain,

− Inventory management of devices,

− Traceability of medical devices, especially for field safety corrective actions,

− Identification of SFDA approved medical devices for procurement activities,

− Identification of counterfeit devices,

− Identification of medical devices at the point of use,

− Identification of medical devices in adverse events,

− Reporting, reviewing and analyzing of adverse event reports,

− Development of processes and systems to reduce medical errors,

− Enable effective consumer-focused information,

− Safe and effective use of devices,

− Safety surveillance of devices,

− Assessment of device performance, and

− Documentation and longitudinal capture of data on medical devices.

Health systems shall take the critical steps necessary to facilitate and leverage the implementation

of UDI throughout KSA by putting systems and processes in place to capture and use UDI in real

time. This includes the documentation of the use or implementation of a device’s UDI in patient’s

electronic health records, the inclusion of UDI in inventory management and billing systems, the

use of UDI in the communication of device safety concerns, and leveraging UDI for easily

accessible clinician and patient information.

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Annexes

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Annex (1): Definitions & Abbreviations

KSA Kingdom of Saudi Arabia

SFDA Saudi Food and Drug Authority

MDS Medical Devices Sector

AI(s) Application Identifier(s)

API Application Program Interface

DI Device Identifier

DM Direct Marking

GHTF/IMDRF Global Harmonization Task Force/International Medical Device

Regulators Forum

GMDN Global Medical Device Nomenclature

GTIN-14 Global Trade Item Number-14

HIBC Health Industry Bar Code

HRI Human Readable Interpretation

IVD InVitro Diagnostic

OEM Original Equipment Manufacturer

OTC Over The Counter

PI(s) Production Identifier(s)

RFID Radio-Frequency IDentification

SaS/SaMD Stand-alone Software/Software as a Medical Device

SAUDI-D Saudi Arabia UDI – Database

UDI Unique Device Identifier

UPC/EAN Universal Product Code/European Article Number

URL Uniform Resource Locator (also known as a web address)

XML Extensible Markup Language

Placing on the Market means the first making available in return for payment or free of

charge of a medical device, with a view to distribution and/or use

within the KSA, regardless of whether it is new or fully refurbished.

Putting into Service means the stage at which a device has been made available to the final

user as being ready for use for the first time in the KSA for its intended

purpose.

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Manufacturer means any natural or legal person with responsibility for design and

manufacture of a medical device with the intention of making it

available for use, under his name; whether or not such a medical

device is designed and/or manufactured by that person himself or on

his behalf by another person.

Establishment means any place of business within the KSA that is involved in the

manufacture and/or placing on the market and/or distribution of

medical devices or acting on behalf of the manufacturer.

Authorized

Representative (AR)

means any natural or legal person established within the KSA who

has received a written mandate from the manufacturer to act on his

behalf for specified tasks including the obligation to represent the

manufacturer in its dealings with the SFDA.

Importer means any natural or legal person in the supply chain who is the first

to make a medical device, manufactured in another jurisdiction,

available in the KSA.

Distributor means any natural or legal person in the supply chain who, on his own

behalf, furthers the availability of a medical device to the end user.

User means the health care institution, professional or patient using and /or

maintaining medical devices.

Supply Chain means different elements of the distribution activities of a medical

device occurring between it being available for importation into the

KSA and it being put into service.

Medical Device

Marketing

Authorization

(MDMA) Number

means the code assigned by the SFDA to one or more medical

devices, that have been included in a single marketing authorization

application, to indicate these devices are authorized to be placed on

the KSA market.

National Registry

Number

means the number issued to a person by the SFDA under the

establishment registration provisions of the Medical Devices Interim

Regulation.

Medical Device

National Listing

Number

means the code assigned by the SFDA to a single medical device to

indicate the device is authorized to be placed on the KSA market and

facilitate traceability.

Medical Device means any instrument, apparatus, implement, machine, appliance,

implant, in vitro reagent or calibrator, software, material or other

similar or related article:

A. Intended by the manufacturer to be used, alone or in combination,

for human beings for one or more of the specific purpose(s) of:

− Diagnosis, prevention, monitoring, treatment or

alleviation of disease;

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− Diagnosis, monitoring, treatment, alleviation of or

compensation for an injury or handicap;

− Investigation, replacement, modification, or support of

the anatomy or of a physiological process;

− Supporting or sustaining life;

− Control of conception;

− Disinfection of medical devices;

− Providing information for medical or diagnostic

purposes by means of in vitro examination of specimens

derived from the human body;

and

B. Which does not achieve its primary intended action in or on the

human body by pharmacological, immunological or metabolic

means, but which may be assisted in its intended function by such

means.

In-Vitro Medical

Device

means a medical device, whether used alone or in combination,

intended by the manufacturer for the in-vitro examination of

specimens derived from the human body solely or principally to

provide information for diagnostic, monitoring or compatibility

purposes. This includes reagents, calibrators, control materials,

specimen receptacles, software and related instruments or apparatus

or other articles.

Accessory means a product specifically intended by its manufacturer to be used

together with one or several particular medical device(s) or in vitro

diagnostic medical device(s) to enable the device(s) to be used in

accordance with its/their intended purpose(s) or to specifically and

directly assist the medical functionality of the medical device(s) in

view of its/their intended purpose(s).

Implantable Device means any device, including those that are partially or wholly

absorbed, which is intended:

− To be totally introduced into the human body or,

− To replace an epithelial surface or the surface of the eye,

by surgical intervention which is intended to remain in place after the

procedure.

Any device intended to be partially introduced into the human body

through surgical intervention and intended to remain in place after the

procedure for at least 30 days is also

Active Implantable

Medical Device

means any implantable device, the operation of which depends on a

source of energy other than that generated by the human body for that

purpose, or by gravity, and which acts by changing the density of or

converting that energy. Devices intended to transmit energy,

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substances or other elements between an active device and the patient,

without any significant change, shall not be deemed to be active

devices. Software shall also be deemed to be an active device.

Configurable Device means a device that consists of several components which can be

assembled by the manufacturer in multiple configurations. The

individual components may be medical devices themselves.

Fully Refurbished

Medical Device

means a used device that has been returned to a state which would

allow it to be subject to the same conformity assessment procedures

as applied to the original device.

Reusable Devices means those devices that require cleaning, disinfection, sterilization

or refurbishing between uses on different patients.

Single Use Medical

Device

means a medical device intended for use once, on an individual

patient for a single procedure, and then should be discarded.

Kit means any combination of two or more different devices (UDI-DIs),

regardless of whether they are finished devices, labeled, intended to

be used together, created for the convenience of the user, subject to

UDI, or marked with UDI, that are packaged together to achieve a

common intended use and are being distributed as a medical device.

Specific kinds of kits include procedure packs/convenience kits.

Generic Device Group means a set of devices having the same or similar intended uses or

commonality of technology allowing them to be classified in a generic

manner not reflecting specific characteristics.

Custom-Made Medical

Device

a medical device that, at a minimum, meets the following

requirements:

− It is intended for the sole use of a particular individual; and

− It is specifically made in accordance with a written request of

an authorized healthcare professional, which gives, under

their responsibility, specific design characteristics; and

− It is intended to address the specific anatomo-physiological

features or pathological condition of the individual for whom

it is intended.

Note 1: patient-specific medical devices, adaptable medical devices

and mass-produced medical devices made by means of industrial

manufacturing processes in accordance with the written request of an

authorized healthcare provider, shall not be considered to be custom-

made.

Note 2: ‘Specific design characteristics’ means unique design

specifications that are based on an individual’s specific anatomo-

physiological features or pathological condition, and that cannot be

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proposed by a manufacturer without the involvement of a healthcare

professional during the conception phase. (For example, transmitting

only dimensions/geometric parameters (such as DICOM files from

CT scans) to a manufacturer prior to the production of a medical

device is not sufficient to be considered as giving specific design

characteristics.)

Patient-Specific or

Patient-Matched

Medical Device

a medical device produced by a manufacturer based on a standard

device template model, or specified design envelope (e.g., minimum

and maximum dimensions, mechanical performance limits, and other

clinically relevant factors), that is matched to a patient’s anatomy

using techniques such as scaling of the device based on anatomic

references, or by using the full anatomic features from patient

imaging, and which is produced through a process that is capable of

being validated.

Adaptable Medical

Device

a mass-produced medical device that must be adapted or assembled

at the point of care, in accordance with the manufacturer’s validated

instructions, to suit an individual patient’s specific anatomo-

physiologic features prior to use.

Mass-Produced

Medical Devices

identical medical devices that are produced in continuous production

runs or homogenous batches.

Note: A batch is considered homogeneous when equivalent parts or

materials are manufactured and/or tested in the same manner, without

interruption, typically on the same day or in the same time period, and

produced by the same person, or with the same machine/equipment

set-up and fulfill the same specifications

Investigational Medical

Device

medical device being assessed for safety or performance in a clinical

investigation.

Investigational IVD

Medical Device

in vitro diagnostic medical device that are being assessed for safety

or performance in a performance evaluation study.

Home Use Medical

Device

is a medical device labelled for use by users in any environment

outside of healthcare facility. This includes but not limited to office

environments, schools, and vehicles. If the medical device is intended

to be used in healthcare facilities and outside those facilities, it meets

this definition

Unit of Use DI means a way to associate the use of a device to/on a patient to data

related to that patient in instances when a UDI is not labelled at the

level of the device unit of use (e.g. several device units contained in a

plastic bag).

Unique Device

Identification (UDI)

means a series of numeric or alphanumeric characters that is created

through a globally accepted device identification and coding standard.

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It allows the unambiguous identification of a specific device on the

market. The UDI is comprised of the UDI-DI and the UDI-PI. Note:

The word "Unique" does not imply serialization of individual

production units.

Basic UDI-DI is the main key in SAUDI-D and relevant documentation (e.g.

certificates, declaration of conformity, technical documentation and

summary of safety and clinical performance) to connect devices with

same intended purpose, risk class and essential design and

manufacturing characteristics.

Device Identifier

(UDI-DI)

means a unique numeric or alphanumeric code specific to a device

and that is also used as the "access key" to information stored in a

UDI database.

Direct Marked/Marking

UDI (DM UDI)

means a permanent marking providing the UDI on the device itself.

Production Identifier

(UDI-PI)

means a numeric or alphanumeric code that identifies the unit of

device production. The different types of Production Identifier(s)

include, but are not limited to, serial number, lot/batch number,

software version number, manufacturing date and expiration (use by)

date.

Human Readable

Interpretation (HRI)

a legible interpretation of the data characters as encoded in the UDI.

Automatic

Identification and Data

Capture (AIDC)

means a technology used to automatically capture data. AIDC

technologies include, but are not limited to, bar codes, smart cards,

biometrics and RFID.

Labeling means written, printed or graphic matter,

− Affixed to a medical device or any of its containers or

wrappers,

− Information accompanying a medical device related to its

identification and/or technical description,

− Information accompanying a medical device related to its use,

but excluding shipping documents.

Label means written, printed, or graphic information that is:

− affixed to or appearing on the medical device itself (including

electronic display), or if there is none,

− on the packaging of each unit (wrapper) or multiple devices

(containers), and if none of that exists,

− on a package insert (is used where it is impractical or

inappropriate to affix a label directly on the medical device

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itself or its packaging. Impractical means where physical

constrains prevent this happening).

Among other information, the label contains that name of the device,

the name and address of the manufacturer, the control information

(e.g., lot number, serial number, manufacturing date, expiration (use

by) date), if the device is intended for single use, and whether the

device is an IVD medical device.

Primary Label means the label on the device itself, or, if there is no label on the

device itself, on the package containing the device.

Package means the various levels of homogenous packages that contain a

defined quantity of a single type (a single UDI-DI) of devices, e.g.

each carton or case.

Shipping Container means a container used during the shipment or transportation of

devices, such as a pallet or tote, and whose contents vary both within

the container and from one shipment to another. Shipping container’s

traceability is controlled by a process specific to the applicable

logistics systems.

Radio Frequency

Identification (RFID)

means an AIDC technology that uses communication through the use

of radio waves to exchange data between a reader and an electronic

tag attached to an object, for the purpose of identification.

Field Safety Corrective

Action

means an action taken by a manufacturer to reduce or remove a risk

of death or serious deterioration in the state of health associated with

the use of a medical device that is already placed on the market.

Field Safety Notice means a notification from the SFDA to relevant medical device users

in relation to a Field Safety Corrective Action.

Reportable Adverse

Event

means any adverse event or any technical or medical reason leading

to a Field Safety Corrective Action, which, directly or indirectly,

might lead to or may have led to (a) the death of a patient, a user or

another person or (b) a serious deterioration in their state of health.